Age related macular degeneration (AMD) is the leading cause of irreversible blindness in the developed world. Monthly or as-needed (PRN) dosing strategies of intravitreal ranibizumab have been established as efficacious treatment options for neovascular AMD. More recently, the "Treatand-Extend" dosing regimen (TREX) is being adopted in clinical practice as it represents a patientcentric and economical option, reducing treatment burden by extending injection intervals when possible. However, the efficacy of TREX using ranibizumab monotherapy remains to be defined. Therefore, we performed a systematic review to assess the current evidence for TREX using ranibizumab by searching MEDLINE, Embase and PubMed. Of 1,733 articles identified, nine TREX studies were included in our analysis (n=748 eyes). Average patient age was 79.25 (range: 77.34 -82.00; S.D. 7.27). Baseline BCVA ranged from 48.5 -68.9 ETDRS letters. BCVA improvement was 8.92 letters at one year (range: 6.5 -11.5; S.D. 7.54), as a weighted mean accounting for numbers of study eyes. The weighted mean number of injections at one year was 8.60 (range: 7.3 -12.0; S.D. 1.73). Previously, the landmark ANCHOR and MARINA trials reported gains of 11.3 and 7.2 letters, respectively, using monthly ranibizumab. Chin-Yee et al reported a gain of 3.5 ETDRS letters with 5.3 (S.D. 0.66) PRN ranibizumab injections as weighted means at one year in their recent systematic review. Our analysis suggests that TREX delivers visual outcomes superior to PRN and approaches similar efficacy to monthly injections. Further RCTs are needed to fully evaluate the efficacy and economy of TREX in the long-term.
Purpose To investigate 1-year visual and anatomic outcomes of intravitreal aflibercept for neovascular age-related macular degeneration (nAMD) given at a fixed 8-weekly interval. Methods Retrospective, single-practice data analysis from an electronic medical record system of 255 eyes (223 patients) with treatment-naïve nAMD receiving 8-weekly aflibercept.Results Mean logarithm of the minimum angle of resolution best-corrected visual acuity (BCVA) improved from 0.66 at baseline to 0.50 at month 11 (Po0.0001). Mean central retinal thickness (CRT) decreased from 311μm at baseline to 211μm at month 11 (Po0.0001). Our mean VA gain of eight ETDRS letters was comparable to the VIEW 1 and VIEW 2 Trials' results at the end of year 1. After loading at month 5, mean BCVA was 0.48 (Po0.0001), and mean CRT was 235 μm. At month 5, 143 eyes (56%) were inactive defined by the absence of macular haemorrhage and intraretinal fluid (IRF) and subretinal fluid (SRF) on optical coherence tomography, and 112 eyes (44%) remained active. At month 11, 136 eyes (53%) were inactive, and 119 eyes (47%) remained active. At month 11, 77% of inactive eyes after loading remained inactive, and 77% of the active eyes after loading remained active. At month 11, mean BCVA of the inactive group was 0.51, and mean BCVA of the active group was 0.48 (P = 0.54). Conclusions Aflibercept administered by fixed dosing over 1 year improved VA and macular morphology in treatment-naïve eyes. Active lesions at month 11 do not have worse VA outcomes compared with inactive lesions. The macular status after loading is a reliable indicator of disease activity at the end of year 1.
PurposeTo audit the visual acuity (VA) outcomes achieved at the end of year two in 17 UK centres, which followed the year 1 VIEW protocol in year 1, but a variable approach in year 2 for aflibercept for neovascular macular degeneration (nAMD).Patients and methodsRetrospective data analysis, from an electronic medical record, of a consecutive series of treatment-naive nAMD patients who received aflibercept for 2 consecutive years, having followed the VIEW protocol in year one, defined as eyes having received 7 or 8 injections from baseline.ResultsThe mean number of intravitreal injections (IVI)s during year 2 was 3.7 in 1180 eyes (1083 patients). The mean baseline VA of the whole cohort was 56.3 ETDRS letters, improving to 61.3 at 1 year (+5) and 59.1 (+2.8) at the end of year 2. The mean VA letter score at the end of year 2, stratified by number of IVIs into three groups was as follows: group A, 57.3 (gain of +1.7) (44% of eyes (=3 IVIs)); group B, 59.8 (+3.8) (34% of eyes (4-5 IVIs)); group C, 61.7 (+3.7) (22% of eyes (>/=6 IVIs)). Even though there were VA gains in the three groups over the 2-years, there was a drop in VA in year one to two. Eyes that received >/=6 IVIs (group C) had a smaller reduction of VA during year 2 than those which received =3 IVIs (group A) (P=0.0014).ConclusionsProviding a higher number of injections after a Q8 regime in year 1 results in higher VA gains in year 2 of treatment.
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